Data-waiving justifications
Data-waiving justifications
As a registrant, you are responsible for ensuring that your registration dossier fulfils all the REACH requirements at your tonnage band.
Data waiving refers to omitting some of the information required under REACH Annexes VII-X from your registration. If you need to omit any required information, you need to justify your reasons for not submitting required data.
Possible reasons for not submitting a study in the dossier are indicated in columns 1 and 2 of the relevant requirement in Annexes VII to X of REACH or sections 2 and 3 of Annex XI of REACH.
If your dossier contains data waivers, the following is verified during the completeness check:
- A justification has been provided in line with columns 1 or 2 of the relevant requirement in REACH Annexes VII to X, or in sections 2 and 3 of REACH Annex XI, and that it has been reported in the appropriate IUCLID field.
- If the data waiving justification relies on other information (for example, a classification, a study result or the chemical safety report), this information is also included in the appropriate section of the dossier.
Specific advice
Check the specific advice page if you need more information on:
- Waiving of substances used in the EEA in cosmetic products.
- Registration obligations of Plant protection products.
- Advice on how to prepare a registration dossier containing data waiving:
How to prepare registration and PPORD dossiers manual - chapter 8.6 [EN][PDF] - Advice on how to provide a complete justification for data waiving:
Information on manual verification at completeness check document – chapter 2 [EN][PDF] - Information on registration requirements under REACH:
Guidance on registration – chapter 4.1 [EN][PDF] - Guidance on how to fulfil and report the information requirements in Annexes VII-XI under REACH
Endpoint specific guidance R7a, R7b and R7c [EN][PDF] - Guidance part on Physico-chemical properties, Skin corrosion/irritation, serious eye damage/eye irritation and respiratory tract corrosion/irritation
Endpoint specific guidance (Chapter R.7a) [EN][PDF] - Guidance part on Aquatic toxicity and Degradation
Endpoint specific guidance (Chapter R.7b) [EN][PDF] - Guidance part on Bioconcentration and bioaccumulation, Effects on terrestrial organisms, Toxicokinetics and substances requiring special considerations regarding testing and exposure
Endpoint specific guidance (Chapter R.7c) [EN][PDF] - Q&As on reporting data waiving justifications:
Preparing registration dossiers in IUCLID
If you have questions related to technical completeness check, use ECHA’s contact form:
- Select ‘Technical support’
- I need support with ‘REACH-IT’
- Request type ‘Completeness check’
For questions related to the Validation assistant, see further instruction at: